Diagnostica Stago, Inc. recalls STA UNICALIBRATOR (ref. 00675)
- Recall date
- November 18, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0737-2020
- FDA classification
- Class II
- Brand / firm
- Diagnostica Stago, Inc.
- Sold / distributed
- US: MA ME VT CT NJ NY PA DC MD VA NC SC GA FL AL TN MS KY OH IN MI IA WI MN SD ND MT IL MO KS LA AR OK TX CO AZ NV CA HI OR WA AK
Why it was recalled
A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observed on several External Quality Assessment (EQA) results.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
STA UNICALIBRATOR (ref. 00675)
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